Strengths, challenges, and strategies for implementing pragmatic multicenter randomized controlled trials (RCTs): example of the Personalized Citizen Assistance for Social Participation (APIC) trial

Background Randomized controlled trials (RCTs) are rigorous scientific research designs for evaluating intervention effectiveness. However, implementing RCTs in a real-world context is challenging. To develop strategies to improve its application, it is essential to understand the strengths and challenges of this design. This study thus aimed to explore the strengths, challenges, and strategies for improving the implementation of a pragmatic multicenter, prospective, two-arm RCT evaluating the effects of the Personalized Citizen Assistance for Social Participation (Accompagnement-citoyen Personnalisé d’Intégration Communautaire: APIC; weekly 3-h personalized stimulation sessions given by a trained volunteer over a 12-month period) on older adults’ health, social participation, and life satisfaction. Methods A multiple case study was conducted with 14 participants, comprising one research assistant, seven coordinators, and six managers of six community organizations serving older adults, who implemented the APIC in the context of a RCT. Between 2017 and 2023, qualitative data were extracted from 24 group meetings, seven semi-directed interviews, emails exchanged with the research team, and one follow-up document. Results Aged between 30 and 60 (median ± SIQR: 44.0 ± 6.3), most participants were women from organizations already offering social participation interventions for older adults and working with the public sector. Reported strengths of this RCT were its relevance in assessing an innovative intervention to support healthy aging, and the sharing of common goals, expertise, and strategies with community organizations. Challenges included difficulties recruiting older adults, resistance to potential control group assignments, design complexity, and efforts to mobilize and engage volunteers. The COVID-19 pandemic lockdown and health measures exacerbated challenges related to recruiting older adults and mobilizing volunteers and complicated delivery of the intervention. The strategies that mostly overcame difficulties in recruiting older adults were reducing sample size, simplifying recruitment procedures, emphasizing the health follow-up, extending partnerships, and recognizing and supporting volunteers better. Because of the lockdown and physical distancing measures, the intervention was also adapted for remote delivery, including via telephone or videoconferencing. Conclusion Knowledge of the strengths and challenges of pragmatic RCTs can contribute to the development of strategies to facilitate implementation studies and better evaluate health and social participation interventions delivered under real-life conditions. Trial registration NCT03161860; Pre-results. Registered on May 22, 2017. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-024-08248-w.


Background and rationale 6a
Pages 2-6 This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.

Interventions 11a
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.The participants did not receive any interventions but implemented the intervention.

11b
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.The participants did not receive any interventions but implemented the intervention.

11c
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.The participants did not receive any interventions but implemented the intervention.

11d
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.The participants did not receive any interventions but implemented the intervention.

Outcomes 12
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.The participants did not receive any interventions but implemented the intervention.

Participant timelime 13
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.The participants did not receive any interventions but implemented the intervention.

Sample size 14
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.The design is a multiple case study.

Recruitment 15
Participants were recruited from organizations implementing the intervention (APIC) as part of the APIC-RCT.

Methods: Assignment of interventions (for controlled trials)
Allocation: Sequence generation 16a NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.

Allocation concealment mecanism 16b
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.

Implementation 16c
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.

Blinding (masking) 17a
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.

17b
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.

Data collection 18a
Pages 8-9 18b NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.The participants did not receive any interventions but implemented the intervention.

Data management 19
The qualitative data collected were stored on a secure Sharepoint.

20c
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.The participants did not receive any interventions but implemented the intervention.

Data monitoring 21a
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.

21b
There were no interim analyses for this study.

Harms 22
There were no adverse events for this study.

Auditing 23
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.

Research ethics and approval 24
The study was approved by the Research Ethics Committee of the University Institute of Geriatrics of Sherbrooke Health and Social Services Centre (MP-22-2014-383).

Protocol amendments 25
There were no protocol amendments for this study.

Consent or assent 26a
A research coordinator from the principal investigator's team was the person responsible for obtaining informed consent or assent from potential participants.

26b
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.

Confidentiality 27
All data collected were anonymized when recorded in a secure file.

Declaration of interests 28
The authors declare that they have no competing interests.

Access to data 29
Data are available from the corresponding author (principal investigator) upon request.
Ancillary and posttrial care

30
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.

Dissemination policy 31a
The results of this study will be disseminated through scientific publications and presentations at national and international conferences.

31b
The eligibility of authors meets the following 4 criteria: 1. Contribute significantly to at least one of the following 3 stages: -Design and implementation of the work plan -Carrying out experiments or collecting data -Analysis and interpretation of results 2. Participate in the drafting or critical revision of the intellectual content of the document 3. Approve the final version of the document 4. Defend the outline of the document and the content corresponding to his/her contribution.Finally, a professional English translator revised the language and grammar of the document.

31c
Protocol and dataset are available from the corresponding author (principal investigator) upon request.

Informed consent materials 32
See Appendices

Biological specimens 33
NA.This study is a qualitative study carried out on the implementation of a pragmatic multicenter, prospective, two-arm RCT.*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items.Amendments to the protocol should be tracked and dated.The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons "Attribution-NonCommercial-NoDerivs 3.0 Unported" license.Nous sollicitons votre participation à un projet de recherche parce qu'en tant que coordonnateur, vous êtes un acteur clé quant à l'implantation de l'APIC dans votre communauté et une source d'information de choix.
Ce formulaire d'information et de consentement vous explique le but de ce projet de recherche, les procédures, les risques et inconvénients ainsi que les avantages, de même que les personnes avec qui communiquer au besoin.Il peut contenir des mots que vous ne comprenez pas.Nous vous invitons à poser toutes les questions nécessaires au chercheur responsable du projet ou aux autres personnes affectées au projet de recherche et à leur demander de vous expliquer tout mot ou renseignement qui n'est pas clair.
Un compte-rendu de chacun des entretiens vous sera envoyé par courriel et un membre de l'équipe de recherche communiquera avec vous dans la semaine suivant la rencontrer afin de valider ces informations.

AVANTAGES POUVANT DÉCOULER DE VOTRE PARTICIPATION AU PROJET DE RECHERCHE
Il se peut que vous retiriez un bénéfice personnel de votre participation à ce projet de recherche, mais nous ne pouvons vous l'assurer.Par ailleurs, les informations découlant de ce projet de recherche pourraient contribuer à l'avancement des connaissances relatives aux interventions de participation sociale offertes aux aînés.
Le responsable de ce projet de recherche, le comité d'éthique de la recherche ou l'organisme subventionnaire peuvent mettre fin à votre participation, sans votre consentement.Cela peut se produire si de nouvelles découvertes ou informations indiquent que votre participation au projet n'est plus dans votre intérêt, si vous ne respectez pas les consignes du projet de recherche ou encore s'il existe des raisons administratives d'abandonner le projet.

CONFIDENTIALITÉ
Durant votre participation à ce projet de recherche, les membres de l'équipe de recherche recueilleront, dans un dossier de recherche, les renseignements vous concernant et nécessaires pour répondre aux objectifs de ce projet de recherche.
Cependant, aucune publication ou communication scientifique ne renfermera quoi que ce soit qui puisse permettre de vous identifier.

COMPENSATION
Vous ne recevrez pas de compensation financière pour votre participation à ce projet de recherche.

Nom du chercheur
Signature Date

(lettres moulées)
We're asking you to take part in a research project because, as a coordinator, you're a key player in the implementation of APIC in your community, and a prime source of information.
However, before agreeing to participate in this project, please take the time to read, understand and carefully consider the following information.If you agree to participate in this research project, you will be asked to sign the consent form at the end of this document, and we will provide you with a copy for your records.
This information and consent form explains the purpose of this research project, the procedures, the risks and inconveniences as well as the benefits, and who to contact if necessary.It may contain words you do not understand.We invite you to ask any questions you may have to the researcher in charge of the project or other people involved in the research project, and to ask them to explain any words or information that are not clear.

NATURE AND OBJECTIVES OF THE RESEARCH PROJECT
Currently, interventions aimed at promoting the social participation of seniors living at home remain rare and discontinuous in Quebec.Moreover, little is known about the factors favoring and hindering the implementation of interventions designed to promote the social participation of seniors, hence the relevance of this research project, which aims to document the implementation of an Accompagnement-citoyen personnalisé d'intégration communautaire (APIC) intervention in 5 Quebec community organizations offering activities and services to seniors with disabilities.

PROGRESS OF THE RESEARCH PROJECT
Your participation in this research consists of being observed during two monthly meetings with volunteer coaches in your area, giving two semi-structured individual interviews, and completing a socio-demographic questionnaire.
Observation of two monthly meetings with volunteer coaches During your facilitation, you will be observed at two monthly meetings with the volunteer coaches in your area, in order to document the implementation in your community.These two meetings will be selected at random (approximately 6 and 12 months after the start of implementation).
Semi-structured interviews Following the observation of each of these monthly meetings, you will be asked to conduct a one-on-one interview to document the implementation of APIC in your community.These meetings, held at a location of your choice, will last between 60 and 90 minutes.If necessary, a could be held to clarify and deepen certain topics.
A report of each interview will be sent to you by e-mail, and a member of the research team will contact you within a week of the meeting to validate this information.
Each interview will be recorded on digital audio tape.

Socio-demographic questionnaire
We'll also ask you to complete a questionnaire about your personal characteristics during the first interview.

DISADVANTAGES THAT MAY ARISE FROM YOUR PARTICIPATION IN THE RESEARCH PROJECT
There are no disadvantages to taking part in the study, apart from the time required for interviews and completing the socio-demographic questionnaire.You can take a break at any time, if you wish.

ADVANTAGES CAN BECOME FROM YOUR PARTICIPATION
IN THE RESEARCH PROJECT You may derive some personal benefit from your participation in this research project, but we cannot assure you of this.On the other hand, the information derived from this research project could contribute to the advancement of knowledge about social participation interventions for seniors.

VOLUNTARY PARTICIPATION AND OPT-OUT
Your participation in this research project is voluntary.You are therefore free to refuse to take part.You may also withdraw from this project at any time, without giving any reason, by informing the research team.Your decision not to participate or to withdraw from the research project will have no effect on your relationship with the research team.
The person in charge of this research project, the research ethics committee or the funding organization may terminate your participation without your consent.This can happen if new findings or information indicate that your participation in the project is no longer in your best interest, if you fail to comply with the research project guidelines, or if there are administrative reasons for abandoning the project.
If you withdraw or are withdrawn from the project, the information already collected will nevertheless be retained, analyzed or used to ensure the integrity of the project.
Any new knowledge acquired during the course of the project that could have an impact on your decision to continue participating in this project will be communicated to you promptly.

PRIVACY
During your participation in this research project, members of the research team will collect, in a research file, information about you that is necessary to meet the objectives of this research project.This information will include interview reports as well as socio-demographic information such as your age and education, which you will have answered during this project.
All such information will remain strictly confidential to the extent permitted by law.To preserve your identity and the confidentiality of the information, you will be identified only by a code number.The key to the code linking your name to your research file will be kept by the researchers in charge for a period of 5 years following the end of the project.This key will then be securely destroyed in accordance with the standards in force at the CIUSSS de l'Estrie-CHUS Research Ethics Board.
The results of this research project may be published in specialized journals or discussed in scientific circles.However, no publication or scientific communication will contain anything that could identify you.
Digital audio tapes will be destroyed as soon as the reports have been transcribed.
For monitoring and control purposes, your research file may be consulted by persons mandated by the CIUSSS de l'Estrie-CHUS Research Ethics Board, by the establishment or by a person appointed by an authorized organization.All these persons and organizations adhere to a policy of strict confidentiality.
You have the right to consult your research file to verify the information collected and have it corrected if necessary, for as long as the people in charge of the project hold this information.However, in order to preserve the scientific integrity of the project, you may only have access to some of this information once your participation has ended.

COMPENSATION
You will not receive any financial compensation for your participation in this research project.

IN THE EVENT OF LOSS
By agreeing to participate in this research project, you do not waive any of your rights and you do not release those responsible for this research project, Initials Version May 29, 2018 CONSENT I have read this information and consent form.I acknowledge that the research project has been explained to me, that my questions have been answered and that I have been given sufficient time to make a decision.
After consideration, I consent to participate in this research project under the conditions stated herein.A signed and dated copy of this information and consent form will be given to me.

Name of participantSignature of participant Date
(block letters) I declare that I have explained to the participant the terms of the research project and of this information and consent form, and that I have answered the questions he asked me.A signed and dated copy of the document has been given to the participant.
Name of person whoSignature Date consent obtained (block letters)

THE RESEARCHER'S COMMITMENT
I certify that the terms of this information and consent form have been explained to the participant, that any questions he or she may have in this regard have been answered, and that it has been made clear to him or her that he or she remains free to terminate his or her participation without prejudice.I undertake, together with the research team, to respect what has been agreed in the information and consent form and to give a signed and dated copy to the participant.
Ce formulaire d'information et de consentement vous explique le but de ce projet de recherche, les procédures, les risques et inconvénients ainsi que les avantages, de même que les personnes avec qui communiquer au besoin.Il peut contenir des mots que vous ne comprenez pas.Nous vous invitons à poser toutes les questions nécessaires au chercheur responsable du projet ou aux autres personnes affectées à l'étude et à leur demander de vous expliquer tout mot ou renseignement qui n'est pas clair.Un compte-rendu de chacun des entretiens vous sera envoyé par courriel et un membre de l'équipe de recherche communiquera avec vous dans la semaine suivant la rencontre afin de valider ces informations.

NATURE ET OBJECTIFS DU PROJET DE RECHERCHE
Chaque entretien sera enregistré sur une bande audionumérique.

CONFIDENTIALITÉ
Durant votre participation à ce projet de recherche, les membres de l'équipe de recherche recueilleront, dans un dossier de recherche, les renseignements vous concernant et nécessaires pour répondre aux objectifs de ce projet de recherche.
sign the consent form at the end of this document and we will provide you with a copy for your records.
This information and consent form explains the purpose of this research project, the procedures, the risks and inconveniences as well as the benefits, and who to contact if necessary.It may contain words you do not understand.We encourage you to ask any questions you may have to the investigator in charge of the project or other people involved in the study, and to ask them to explain any words or information that are not clear.

NATURE AND OBJECTIVES OF THE RESEARCH PROJECT
Currently, interventions aimed at promoting the social participation of seniors living at home remain rare and discontinuous in Quebec.Moreover, little is known about the factors favoring and hindering the implementation of interventions designed to promote the social participation of seniors.Hence the relevance of this research project, which aims to document the implementation of an Accompagnement-citoyen personnalisé d'intégration communautaire (APIC) in 5 Quebec community organizations offering activities and services to seniors with disabilities.

PROGRESS OF THE RESEARCH PROJECT Individual interviews
Your participation in this research involves two individual semi-structured interviews, approximately 6 and 12 months after the start of implantation.Each interview will last between 60 and 90 minutes, and will take place at a location of your choice.If necessary, an additional interview may be held to clarify and deepen certain issues.
A report of each interview will be sent to you by e-mail, and a member of the research team will contact you within a week of the meeting to validate this information.
Each interview will be recorded on digital audio tape.Sociodemographic questionnaire We'll also ask you to complete a questionnaire about your personal characteristics during the first interview.

DISADVANTAGES THAT MAY ARISE FROM YOUR PARTICIPATION IN THE RESEARCH PROJECT
There are no disadvantages to taking part in the study, apart from the time required for interviews and completing the socio-demographic questionnaire.You can take a break at any time, if you wish.

BENEFITS OF PARTICIPATING IN THE RE SEARCH PROJECT
You may derive some personal benefit from your participation in this research project, but we cannot assure you of this.On the other hand, the information derived from this research project could contribute to the advancement of knowledge about social participation interventions for seniors.

VOLUNTARY PARTICIPATION AND OPT-OUT
Your participation in this research project is voluntary.You are therefore free to refuse to take part.You may also withdraw from this project at any time, without giving reasons, by informing the research team.Your decision not to participate or to withdraw from the research project will have no effect on your relationship with the research team.
The person in charge of this research project, the research ethics committee, the funding agency or the sponsor may terminate your participation without your consent.This can happen if new findings or information indicate that your participation in the project is no longer in your best interest, if you fail to comply with the research project guidelines, or if there are administrative reasons to abandon the project.
If you withdraw or are withdrawn from the project, the information already collected will nevertheless be retained, analyzed or used to ensure the integrity of the project.
Any new knowledge acquired during the course of the project that could have an impact on your decision to continue participating in this project will be communicated to you promptly.

PRIVACY
During your participation in this research project, members of the research team will collect, in a research file, information about you that is necessary to meet the objectives of this research project.This information will include the minutes of the interview as well as sociodemographic information such as your age and education, which you will have answered during this project.
All such information will remain strictly confidential to the extent permitted by law.To preserve your identity and the confidentiality of the information, you will be identified only by a code number.The key to the code linking your name to your research file will be kept by the researchers in charge for a period of 5 years following the end of the project.This key will then be securely destroyed in accordance with the standards in force at the CIUSSS de l'Estrie-CHUS Research Ethics Board.
The results of this research project may be published in specialized journals or be the subject of scientific discussions.